ULTRA THERAPY PAIN RELIEF

Manufacturer: Cal Pharma
Effective date: 2019-11-23
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: legacy-cache
Hydrated at: 2026-08-01 23:57:34

Label at a glance#

ProductULTRA THERAPY PAIN RELIEF

Active ingredientMENTHOL, METHYL SALICYLATE, CAPSAICIN

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

METHYL SALICYLATE (28%)

MENTHOL (10%)

CAPSAICIN (0.025%)

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

INDICATIONS & USAGE SECTION

USE

- TEMPORARILY RELIEVES MILD ACHES AND PAINS OF MUSCLE AND JOINTS

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE ON OPEN WOUNDS, CUTS, DAMAGED OR INFECTED SKIN AS WELL AS IN THE EYES, MOUTH, GENITALS OR OTHER MUCOUS MEMBRANE

STOP USE AND CONSULT YOUR PHYSICIAN IF PAIN IS PERSISTENT OR WORSENS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

- APPLY ON CLEAN SKIN AND GENTLY RUB OVER AREA WITH PAIN. DO NOT USE MORE THAN 4 TIMES A DAY. WASH HANDS AFTER LOTION IS APPLIED AND RUBBED ONTO SKIN.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Butterbur Extract, Cetearyl Alcohol and Polysorbate 60, Glucosamine HCl, Glyceryl Stearate and Peg 100 Stearate, Hydroxypropyl Methylcellulose, Isopropyl Palmitate, Phenoxyethanol, Ethylhexylglycerin, Pine Bark Extract, Prickly Ash Bark Extract, Propylene Glycol, Sichuan Peppercorn Extract , Stearyl Alcohol, Water Deionsed, Willowbark Extract, Wintergreen Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Therapy Gels_Pain_20130423

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1372560	Capsaicin/Menthol/Methyl salicylate (Topical)	capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 280 MG/ML Topical Lotion	SCD Active

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55628-1001-2	2024-03-28	C162847	48780-1	d6a99b39-b98a-a426-e053-dadaa90af4c2	3d42ba94-0a53-4cc2-bda4-a4284c28c974
55628-1001-2	2022-01-28	C162847	48780-1	d6a99b39-b98a-a426-e053-dadaa90af4c2	3d42ba94-0a53-4cc2-bda4-a4284c28c974

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	10
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	10
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	10
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	10
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	10
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	10
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	10
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	10
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	10
GAULTHERIA PROCUMBENS LEAF	INACTIVE INGREDIENT	2125M16OWN	10
GLUCOSAMINE HYDROCHLORIDE	INACTIVE INGREDIENT	750W5330FY	10
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	10
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	10
MARITIME PINE	INACTIVE INGREDIENT	50JZ5Z98QY	10
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	10
PETASITES HYBRIDUS LEAF	INACTIVE INGREDIENT	JOS311ZC1G	10
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	10
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	10
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	10
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	10
WATER	INACTIVE INGREDIENT	059QF0KO0R	10
WILLOW BARK	INACTIVE INGREDIENT	S883J9JDYX	10
ZANTHOXYLUM AMERICANUM BARK	INACTIVE INGREDIENT	A4KL1HMZ7T	10
ZANTHOXYLUM BUNGEANUM WHOLE	INACTIVE INGREDIENT	WH9894JM8K	10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

ULTRA THERAPY PAIN RELIEF
MENTHOL, METHYL SALICYLATE, CAPSAICIN
MENTHOL
METHYL SALICYLATE
SALICYLIC ACID
CAPSAICIN
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
PETASITES HYBRIDUS LEAF
CETOSTEARYL ALCOHOL
POLYSORBATE 60
GLUCOSAMINE HYDROCHLORIDE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
HYPROMELLOSES
ISOPROPYL PALMITATE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
MARITIME PINE
ZANTHOXYLUM AMERICANUM BARK
PROPYLENE GLYCOL
ZANTHOXYLUM BUNGEANUM WHOLE
STEARYL ALCOHOL
WATER
WILLOW BARK
GAULTHERIA PROCUMBENS LEAF

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55628-1001	55628-1001-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
METHYL SALICYLATE	LAV5U5022Y	ACTIB
CAPSAICIN	S07O44R1ZM	ACTIB
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	71DD5V995L	IACT
PETASITES HYBRIDUS LEAF	JOS311ZC1G	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
GLUCOSAMINE HYDROCHLORIDE	750W5330FY	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
MARITIME PINE	50JZ5Z98QY	IACT
ZANTHOXYLUM AMERICANUM BARK	A4KL1HMZ7T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
ZANTHOXYLUM BUNGEANUM WHOLE	WH9894JM8K	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
WATER	059QF0KO0R	IACT
WILLOW BARK	S883J9JDYX	IACT
GAULTHERIA PROCUMBENS LEAF	2125M16OWN	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 182 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	AEROSOL, SPRAY / TOPICAL		397 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, DELAYED RELEASE / ORAL		79 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GRANULE, FOR SUSPENSION / ORAL	1.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	221 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE / ORAL		1488 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SHAMPOO / TOPICAL	14.55 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	LOTION / TOPICAL		1140 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	OINTMENT / TOPICAL	2 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	OINTMENT / TOPICAL		569 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, ORALLY DISINTEGRATING / ORAL		41 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SYRUP / ORAL		250 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	SUPPOSITORY / VAGINAL	8.5 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	CREAM / VAGINAL		425 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 27 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
14bcbaf9-76ad-f8ba-e063-6294a90a91f6			3d42ba94-0a53-4cc2-bda4-a4284c28c974	2024-03-28	Warnings	Exact identifier spl set id: 3d42ba94-0a53-4cc2-bda4-a4284c28c974

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.